# K093256: Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Nov 17, 2009 after 29 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960064 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960064: Temno Achieve Biopsy Needle, Bauer Medical, Inc. (1996) Summary page 1.

## Indications for use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.

Source page: https://510kreport.com/device/K093256
Methodology: https://510kreport.com/methodology